Kornimate/medical-research-clean huggingface dataset:
management of postoperative discomfort in young children following dental rehabilitation under general anesthesia

Conditions: Pain, Postoperative

Summary: the purpose of this study is to investigate the effectiveness of various oral analgesic regimens in minimizing post-operative pain and discomfort in young children following dental rehabilitation under general anesthesia (drga). in this randomized controlled trial, three analgesic regimens following drga in franciscan children's hospital will be compared using both self-report and behavioral measures. the analgesic therapies to be investigated are ibuprofen monotherapy, alternating ibuprofen and acetaminophen dual-therapy, and combined ibuprofen and acetaminophen dual-therapy. for the purposes of this study, combined therapy is defined as the simultaneous administration of acetaminophen and ibuprofen at regular intervals, whereas alternating therapy is defined as one analgesic (acetaminophen or ibuprofen) administered within a 3 hour interval of the other.


Eligibility criteria:
inclusion criteria: * american society of anesthesiologists (asa) i-ii * requiring oral rehabilitation under general anesthesia * possess legal guardians proficient in english * not have a history of any adverse/allergic reaction to nonsteroidal anti-inflammatory drugs (nsaids) or acetaminophen exclusion criteria: * asa iii or iv * asthma diagnosis * contraindication to acetaminophen or ibuprofen

Keywords: dental rehabilitation under general anesthesia (drga) dental surgery patients 4-6 years acetominophen ibuprofen pacing analgesics
cognitive behavioral social skills training for improving social functioning in people with schizophrenia

Conditions: Schizophrenia

Summary: this study evaluated the effectiveness of cognitive behavioral social skills training versus goal-focused supportive contact in improving social functioning in people with schizophrenia.

schizophrenia is a chronic, severe, and disabling brain disorder. people with schizophrenia sometimes hear voices others don't hear, believe that others are broadcasting their thoughts to the world, or become convinced that others are plotting to harm them. these symptoms make it difficult for people with schizophrenia to interact normally and establish healthy social relationships with others. cognitive behavioral social skills training (cbsst) is a group behavioral therapy intervention that focuses on improving cognitive and metacognitive impairments and social skills deficits that interfere with normal functioning in people with schizophrenia. goal-focused supportive contact (gfsc) is a group therapy intervention that focuses on helping people with schizophrenia to verbalize their problems or worries and to seek advice from fellow group members. this study evaluated the effectiveness of cbsst versus gfsc in improving social functioning in people with schizophrenia. the study will assessed changes in cognition, psychotic symptoms, and use of psychiatric healthcare services. participants in this open label study were randomly assigned to one of the following treatment groups: treatment as usual (tau) plus cbsst or tau plus gfsc. both interventions consist of 2-hour therapy sessions weekly for 36 weeks. groups receiving each intervention do not exceed ten people. cbsst integrates cognitive therapy, social skills training, and neurocognitive compensatory aids. cognitive therapy helps participants challenge unhelpful thoughts and build communication and problem-solving skills. participants receive workbooks that describe the skills and contain homework assignments. gfsc focuses on empowering participants to share problems, worries, or concerns with others who face similar issues. participants share advice with each other, but therapists do not teach skills. outcomes were be assessed at months 4.5, 9, 15, and 21 for all participants.

Eligibility criteria:
inclusion criteria: * dsm-iv diagnosis of schizophrenia or schizoaffective disorder at any stage of illness exclusion criteria: * level of care required at baseline interferes with outpatient group therapy participation (e.g., partial or inpatient hospitalization for psychiatric illness, substance use, or physical illness) * no case manager or care coordinator * medically or psychiatrically unstable for outpatient therapy * exposure to social skills training (sst), cognitive behavioral therapy (cbt), or dialectical behavioral therapy (dbt) within 5 years prior to study entry

Keywords: psychotic disorders schizoaffective disorder cognitive behavioral therapy social skills training
naltrexone effects on alcohol intake

Conditions: Social Drinker

Summary: the purpose of this study is to examine drinking behavior and decision-making while taking naltrexone and placebo. this is a double-blind, randomized, placebo-controlled crossover study. there are two cycles: one cycle on naltrexone and one cycle on placebo.

the study proposed is a 22 to 23 day, double-blind, placebo-controlled crossover study in 60 male and female moderate to heavy alcohol users who are asp40 positive and negative. subjects will undergo a 6 to 7-day cycle taking the first study drug (naltrexone or placebo) with an alcohol self-administration visit in the laboratory bar on the 6th or 7th day of drug. the first alcohol self-administration visit is followed by an 8 to 9 day washout period. subjects then cross over to repeat the cycle while taking the other drug (placebo or naltrexone). on the final day (either day 8 or 9) of the first study drug cycle, the subject will undergo functional imaging (fmri) at the wbic. there will be at least one day in between the 'lab bar' and the fmri scan. the first fmri visit is followed by a 5-6 day washout period. subjects then cross over to repeat the cycle while taking the other drug (placebo or naltrexone). subjects will keep daily diaries of alcohol and medication use throughout the study.

Eligibility criteria:
inclusion criteria: * healthy volunteers who are 21-40 years of age * if female, 7-20 alcoholic drinks must be consumed weekly. * if male, 10-25 alcoholic drinks must be consumed weekly. * if female, must be non-lactating, not pregnant, and using a reliable contraception method (i.e. abstinence, intrauterine device \[iud\], hormonal birth control, or double barrier method \[male condom, female condom, or diaphragm plus a spermicidal agent such as contraceptive foam, jelly or cream\]). * must have a body mass index (bmi) ≥18 and ≤30. * able and willing to provide an informed consent. * able to understand and follow the instructions of the investigator, including the delayed discounting tasks. * have a breath alcohol concentration of less than 0.02 on visits 1, 2, 3, 5, and 6; and 0.00 on visits 4, 4a, 7 and 7a. exclusion criteria: * positive urine drug screen * using cocaine, stimulants (other than nicotine and caffeine), methamphetamine, and/or amphetamines greater than 30 times in the last 24 months * using inhalants, hallucinogens, ecstasy, and/or ketamine greater than 30 times in the last 24 months * current enrollment in an alcohol, or other drug treatment program or current legal problems relating to alcohol, or other drug use, including awaiting trial or supervision by a parole or probation officer * binge drinking more than three times per week (\>5 standard drinks in one session is a binge) * currently trying to quit alcohol use * current dependence on any other psychoactive drug (except nicotine or caffeine) and/or alcohol as determined by the study physician's assessment . * clinically significant medical or psychiatric illness as determined by screening blood tests, medical history, and physical exam performed by the study physician

Keywords: alcohol naltrexone
study to identify patients with advanced/metastatic non small cell lung cancer (nsclc) and alk and ros1 translocation and to establish their therapeutic management (idealk&ros)

Conditions: Non-Small Cell Lung Cancer

Summary: prospective observational study to identify patients with advanced/metastatic nsclc and alk and ros1 translocation and to establish their therapeutic management (idealk\&ros)


Eligibility criteria:
inclusion criteria: for alk incidence substudy * patients with advanced or metastatic non-small cell lung cancer * patients who will be screened for anaplastic lymphoma kinase (alk) rearrangement * age \> 18 years for alk treatment substudy (retrospective and prospective) * age \> 18 years * confirmed anaplastic lymphoma kinase (alk)-positive tumour * patients treated with crizotinib under routine clinical practice * patients with a minimum data registered at the medical history * for the patients that will be recruited prospectively: patients must have a signed informed consent document. for the ros1 treatment sub-study (retrospective only): * age \> 18 years * confirmation of nsclc with ros1-positive translocation * have been eligible to receive treatment with crizotinib according to routine clinical practice since the market launch of the ros1 indication in spain on 8 february 2017 until the opening of the site. * patients should have a predetermined minimum amount of data recorded in their medical records. exclusion criteria: * any patient who does not meet any of the inclusion criteria defined in the previous section, depending on the sub-study for which they are included.

Keywords: alk+, ros1
a study of gemcitabine ± erlotinib and dn-101 versus gemcitabine ± erlotinib and placebo in patients with advanced pancreatic cancer

Conditions: Pancreatic Cancer

Summary: the purpose of this study is to determine the safety and efficacy of an investigational study drug dn-101 (calcitriol) when given in combination with gemcitabine ± erlotinib in the treatment of pancreatic cancer.


Eligibility criteria:
inclusion criteria: * histologically or cytologically confirmed diagnosis of locally advanced and unresectable, or metastatic pancreatic cancer * performance status 0, 1,or 2 * adequate bone marrow, renal and hepatic function exclusion criteria: * prior chemotherapy or radiation therapy for pancreatic cancer * prior treatment for other cancers in last 6 months * cancer of the brain or spine * active uncontrolled infection * hypercalcemia
mr-simulation in radiotherapy for prostate cancer

Conditions: Cancer of the PROSTATE

Summary: to assess the feasibility of acquiring an mr scan in the radiotherapy treatment position as part of the patient's radiotherapy pathway and incorporating the data into our radiotherapy planning systems, so that it can be potentially used to reduce healthy tissue exposure to radiation. subsequently, the protocols and procedures established can be used to put the technique into routine clinical practice.

conventional radiotherapy treatment planning uses computed tomography (ct) scans to provide an accurate 3-d picture of the local anatomy. this helps the planners to maximise the radiation dose delivered to the prostate, whilst minimising the dose to surrounding normal tissue. magnetic resonance imaging (mri) scanning is an established diagnostic imaging technique that provides even clearer images of the local anatomy. however, until recently the technology hasn't existed to allow us to perform mri scans with patients "set-up" in the position required to plan and deliver radiotherapy to the prostate. this study is being performed to assess methods that may allow us to incorporate mri scans into the radiotherapy planning process, which may further increase the accuracy of the treatment, reducing the irradiation of surrounding normal tissue and minimising toxicity.

Eligibility criteria:
inclusion criteria: * written, voluntary, informed consent * age ≥ 18 * ecog performance status ≤ 2 * life expectancy \> 12 months * histologically proven carcinoma of the prostate * radical radiotherapy +/- hormones indicated as the primary treatment modality * staging diagnostic mri of the prostate need to be available for comparison. * adequate organ function and absence of other major concurrent illness, allowing exclusion criteria: * inability to provide informed consent * impaired renal function (serum creatinine of \> 200) * severely impaired liver function * patients with allergies or contra-indications to the gadolinium contrast agent that may be used in the study * severe claustrophobia or inability to tolerate mri scans * general contra-indications to mri including cardiac pacemakers and defibrillators, metallic prosthetic devices, aneurysm clips and metal fragments in the eyes, as defined in mri safety departmental protocols * serious inter-current conditions or other non-malignant illnesses that are uncontrolled or whose control may be affected by participation in this study * any patient who has urinary or faecal incontinence * status greater than or equal to 3
an open label trial to investigate macugen for the preservation of visual function in subjects with neovascular amd

Conditions: Age Related Macular Degeneration (AMD); Macular Degeneration; Choroidal Neovascularization (CNV)

Summary: the purpose of this study is to determine the benefits of treating subjects with neovascular age-related macular degeneration (amd) at an earlier stage of choroidal neovascularization (cnv) as compared to those with established cnv. additionally, the study would like to determine the efficacy of macugen in preserving visual function in those subjects having cnv secondary to neovascular amd.

a decision was made by the sponsor (08 may 2009) to terminate this study early; the study had achieved the primary objective prior to termination. this study was not terminated due to safety reasons.

Eligibility criteria:
inclusion criteria: * evidence of neovascular amd in at least one eye. in subjects with bilateral neovascular amd, only one eye would be eligible for enrollment * baseline visual acuity of greater than or equal to 20/320, or better than 25 etdrs letters in the study eye exclusion criteria: * previous treatment for cnv secondary to amd, including any prior pdt with verteporfin, thermal laser photocoagulation, external beam radiation or transpupillary thermotherapy to the study eye * subjects having subfoveal fibrosis/ scar or atrophy representing \> 25% of the total lesion size

Keywords: neovascular age related macular degeneration choroidal neovascularization
evaluation of clareon vivity/vivity toric

Conditions: Aphakia

Summary: this study seeks to generate clinical data from subjects previously implanted with the clareon vivity/vivity toric intraocular lenses (iols) or clareon monofocal/clareon toric iols. this study will assess key performance endpoints to support clinical benefits statements with model-specific data.

both eyes of a subject must qualify for enrollment into this study. a total of 2 scheduled visits are planned. the visits include a screening visit (visit 0) and a visit after screening (visit 1). the subject must be 90-180 days post second eye implant at the time of visit 1. visit 1 should occur 1 to 14 days after visit 0. subject participation is expected to last approximately 2 weeks.

Eligibility criteria:
key inclusion criteria: * understand and sign an approved informed consent form * previously implanted in both eyes with clareon vivity/clareon vivity toric or clareon monofocal/clareon toric iols for at least 3 months and up to 6 months (90 to 180 days) after second eye implant. * other protocol-defined inclusion criteria may apply. key exclusion criteria: * history of clinically significant ocular co-morbidities that would affect surgical outcomes based on investigator expert medical opinion. * subjects who were targeted to monovision defined as ≥ 1.50 diopter (d) of anisometropia. * clinically significant pco (posterior capsule opacification) affecting vision. * other protocol-defined exclusion criteria may apply.

Keywords: cataract intraocular lens
heart rate regularization in atrial fibrilation and heart failure

Conditions: Heart Failure; Atrial Fibrillation

Summary: the pace-fib trial is a multicentre, randomised, open-label clinical trial. patients older than 18 years, with permanent af, lvef\>40%, average resting heart rate ≤ 110 beats per minute (bpm), at least one hospitalisation due to hf in the previous year and basal nt-probnp level\>900 pg/ml will be randomised to either csp and subsequent av node ablation (intervention group) vs. pharmacologic rate control optimised according to clinical practice guidelines. the impact of both strategies on a composite primary endpoint of all-cause mortality, hf hospitalisation and worsening hf will be evaluated during a 36-month follow-up.

permanent atrial fibrillation (af) causes beat-to-beat heart rate irregularity, which has shown to decrease cardiac output. observational data suggest that heart rate regularization through atrioventricular (av) node ablation and pacemaker implantation improves outcomes in heart failure (hf) patients. however, no trials have been conducted to assess its potential benefit in hf and left ventricular ejection fraction (lvef)\>40%, a population in whom treatment strategies effectively improving outcomes are scarce. the goal of this trial is to assess the benefit of heart rate regularization through av node ablation and conduction system pacing (csp) in patients with permanent af and hf with preserved or mildly reduced systolic function. the investigators hypothesize that heart rate regularization added to physiological pacing - preventing the deleterious effect of right apical pacing - reduces mortality, hf hospitalisations or worsening hf in these patients.

Eligibility criteria:
inclusion criteria: * permanent atrial fibrillation * at least one episode of hospitalisation due to heart failure in the previous 12 months. * left ventricular ejection fraction \> 40% * average resting heart rate ≤ 110 beats per minute * nt-probnp ≥ 900 pg/ml in the 30 days prior to enrollment * age ≥ 18 years * capacity to understand the nature of the study, legal ability and willingness to give informed consent. exclusion criteria: * severe frailty (clinical frailty scale ≥ 7) or comorbidity reducing life expectancy to \< 12 months. * acute heart failure at the time of enrollment or systolic blood pressure \< 80 mmhg in the absence of inotropic agents. * severe chronic kidney disease (estimated glomerular filtration rate ≤ 20 ml/1,73 m2 * severe mitral or aortic valvular heart disease * anaemia (haemoglobin \< 10 g/dl) * morbid obesity (bmi ≥ 35) * severe chronic obstructive pulmonary disease (gold ≥ 3) * presence of a different indication for pacing of implantable cardioverter-defibrillator (icd) * obstructive hypertrophic cardiomyopathy * infiltrative cardiomyopathy (amyloidosis, sarcoidosis, fabry disease, others) * simultaneous participation in a different trial

Keywords: atrial fibrillation; heart failure; conduction system pacing; heart rate regularization
the use of klorsept solution for debriding infected wounds: is it effective and safe? prospective observational study

Conditions: Non-healing Wound; Infected Wound

Summary: klorsept is a debridement solution of necrotic infected tissue promoting wound healing. the aim of this study is to elaborate the effectiveness and safety of this solution.

klorsept is a debridement solution of necrotic infected tissue promoting wound healing. the aim of this study is to elaborate the effectiveness and safety of this solution. this study will include 50 patients suffering from necrotic and infected wounds. several parameters will be evaluated in order to provide the effectiveness and safety of this treatment.

Eligibility criteria:
inclusion criteria: * hospitalized patients with infected wounds who can sign an informed consent exclusion criteria: * patient that can not sign an informed consent * pregnant woman * age less than 18 years * allergy to chlorine

Keywords: safety issue
safety of hib vaccine (bio farma)

Conditions: Healthy

Summary: the objective of this study was to know the safety of hib/prp-t vaccine and immediate reactions within the first 30 minutes after injection.

this trial was an open-label study, no randomization, and no placebo or control group. total 25 young healthy adult (volunteers) followed this trial. the safety was assessed within 24 hours, 48 hours, 72 hours, and 28 days after injection.

Eligibility criteria:
inclusion criteria: * adult (age 18 - 40 years old) * provision of written informed consent * good health according to the clinical investigator * willingness and ability to adhere to the regimen of the study exclusion criteria: * known not enrolled in other study * pregnancy or lactation * known or suspected allergy to any of the vaccine component (by medical history) * history of unusual reaction to any previous vaccination * known or suspected immune deficiency, or use of medication that may influence the immune system * prior respiratory infection * other vaccination during the study, or one week before (inactivated vaccine) or one month (live vaccine) before the study * acute febrile illness (temperature \> 37.5 celsius) * present evidence of serious diseases demanding medical treatment * any significant congenital or chronic disorder

Keywords: adults hib vaccines immunogenicity safety
a study to assess the safety, tolerability, pharmacokinetics, and preliminary efficacy of cd-001 in patients with advanced solid tumors

Conditions: Advanced Solid Tumors

Summary: to assess the safety, tolerability, pk and preliminary efficacy of cd-001 in patients with advanced solid tumors. and to determine the maximum tolerated dose (mtd) and/or recommended phase 2 dose (rp2d).


Eligibility criteria:
inclusion criteria: 1. age ≥ 18 years , regardless of gender. 2. patients with advanced solid tumors that are histologically or cytological confirmed, lacking standard therapy, progressing after adequate standard therapy, or intolerant of standard therapy. 3. ecog score ≤ 2. 4. at least one measurable lesion as defined by recist v1.1. 5. expected survival ≥ 3 months. exclusion criteria: 1. patients with known active central nervous system (cns) and/or leptomeningeal metastases . 2. patients who have undergone major organ surgery within 4 weeks prior to the first dosing, or who are expected to require major surgery during this study, or who have severe unhealed wounds, trauma, ulcers, etc. 3. patients who have previously undergone a major organ transplant, bone marrow transplant, or allogeneic stem-cell transplant. 4. patients who have a past or current history of active or chronic autoimmune disease and who have required systemic therapy within the past 2 years or is receiving systemic therapy for an autoimmune or inflammatory disease. 5. patients who have received anti-tumor therapy within 4 weeks or 5 drug half-lives (whichever is shorter) prior to the first dosing. 6. at screening as determined by the investigator, the presence of any serious or uncontrollable disease or associated risk. 7. patients with a history of ≥ grade 3 (ctcae) immune-related adverse events (iraes) during prior anti-tumor therapy or permanent drug discontinuation due to iraes. 8. patients who have had a pulmonary embolism within 6 months prior to first dosing or have interstitial pneumonia at screening.
effectiveness of major ozone autohemotherapy in the treatment of fibromyalgia syndrome

Conditions: Fibromyalgia Syndrome

Summary: patients who were admitted to the physical medicine and rehabilitation (pmr) outpatient clinic of our hospital between january 2017 and december 2020 and were treated with major ozone autohemotherapy with a diagnosis of fibromyalgia syndrome will include to the study. visual anolog scale (vas), fibromyalgia impact questionnare (fiq) and short form health survey-36 (sf-36) scores of the patients before and after treatment were recorded. statistical analysis of these outcome scores will be made.


Eligibility criteria:
exclusion criteria: * has pregnancy, * has primary romatological disease, * has primary psychiatric disease * \ 60 years old patients